Study coordination for current and future clinical trials conducted in Genetics Division of Casey Eye Institute. Clinical trial participants will include adults and children with inherited retinal degenerations causing progressive vision loss.
Subject Management: Identify potential subjects through chart review, discussion with investigator or other mechanisms; assists PI in the identification and eligibility of new protocol subjects; schedules, orders, communicates assessments and appointments with assistance as needed; assists with clinical trial consenting process and ensures accurate completion of appropriate forms and source documentation.
Protocol Management: Assists with feasibility evaluation for new trials; performs pre-screening and enrollment supporting activities as appropriate with assistance as needed; communicates with regulatory PM to ensure approvals are in place; works with study monitors to ensure compliance and quality with assistance as needed; ensures adherence to protocol and regulations.
Study Set Up: Develop new study-specific processes, assists with ensuring everything is in place for the first subject enrollment.
Documentation: Document in research charts or medical record as appropriate with assistance as needed; reviews patient questionnaires for completeness with assistance as needed.
Specimen Processing: Train in basic phlebotomy, be willing to handle and process blood and urine specimens and ship specimens appropriately.
Communication: Ensures all internal parties are aware of required study activities to include: investigators, study participants, research teams, ancillary services; Facilitates effective communication with sponsor for resolution of questions and issues, enrollment reports, SAE/UP reporting; may facilitate team meetings; involvement in setting meeting agenda.
Data management: May assist with basic elements of CRF development with assistance as needed. May assist with collection and transcription of all source data into study databases and Case Report Forms in a timely and high quality manner.
Regulatory: Regulatory submissions to include RNI, protocol deviations, may assist or participate with other regulatory requirements at the request of the manager with assistance as needed.
Bachelors Degree with major courses in field of research and 1 to 3 years of relevant experience, OR AA/RN (2 yr) and 3 years of relevant experience.
BLS certification through American Heart Association (AHA), provider level.
Degree in Biology, Genetics, or related field
Previous clinical and/or research experience, basic medical experience (vital signs)
Phlebotomy certification preferred, or willingness to get certified
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